Study Stopped
Business Decision: No Safety or Efficacy Concerns
A Study of TAK-659 in Combination With NKTR-214 in Participants With Advanced Non-Hodgkin Lymphoma (NHL)
A Phase 1b Study of TAK-659 in Combination With NKTR-214 in Patients With Advanced Non-Hodgkin Lymphoma
2 other identifiers
interventional
N/A
2 countries
6
Brief Summary
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) for TAK-659 when administered in combination with NKTR-214.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2019
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2018
CompletedFirst Posted
Study publicly available on registry
December 11, 2018
CompletedStudy Start
First participant enrolled
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2021
CompletedFebruary 8, 2023
February 1, 2023
2.6 years
December 10, 2018
February 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
MTD of TAK-659 in Combination with NKTR-214
3 weeks after last dose of last participant in dose escalation or up to 6 months
RP2D of TAK-659 in Combination with NKTR-214
3 weeks after last dose of last participant in dose escalation or up to 6 months
Secondary Outcomes (9)
Cmax: Maximum Observed Plasma Concentration for TAK-659
Cycle 1 and Cycle 2: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (cycle length=21 days)
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-659
Cycle 1 and Cycle 2: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (cycle length=21 days)
AUCτ: Area Under the Plasma Concentration-time Curve From Time During the Dosing Interval for TAK-659
Cycle 1 and Cycle 2: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (cycle length=21 days)
Cmax: Maximum Observed Plasma Concentration for NKTR-214
Cycle 1 Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose (cycle length=21 days)
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for NKTR-214
Cycle 1 Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose (cycle length=21 days)
- +4 more secondary outcomes
Study Arms (2)
Dose Escalation: TAK-659 + NKTR-214
EXPERIMENTALTAK-659 tablet, orally, once daily along with NKTR-214, infusion, intravenously, once on Day 1 in a 21-day treatment cycle, until disease progression, unacceptable toxicities, or discontinuation by participant. The dose escalation phase will determine the MTD or RP2D of TAK-659. Dose escalation of TAK-659 will be based on available safety and tolerability data.
Safety Expansion: TAK-659 + NKTR-214
EXPERIMENTALTAK-659, tablet, orally, once daily along with NKTR-214, infusion, intravenously, once on Day 1 of 21-day treatment cycle, until disease progression, unacceptable toxicities, or discontinuation by participants. TAK-659 and NKTR-214 MTD/RP2D will be determined from the dose escalation phase.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed diagnosis of advanced B-cell NHL, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), or mantle cell lymphoma (MCL) (Waldenstrom macroglobulinemia \[WM\] and chronic lymphocytic leukemia \[CLL\]/small lymphocytic leukemia \[SLL\] are excluded).
- Radiographically or clinically measurable disease with at least 1 target lesion per (greater than \[\>\] 1.5 centimeter \[cm\] in the longest diameter for a lymph node or nodal mass, or \>1.0 cm in the longest diameter for extranodal disease) Lugano 2014 criteria for malignant lymphoma.
You may not qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 and life expectancy of \>3 months.
- Must have adequate organ function.
- Recovered (that is, less than or equal to \[\<=\] Grade 1 toxicity) from the clinically significant reversible effects of prior anticancer therapy.
- Central nervous system (CNS) lymphoma; active brain or leptomeningeal metastases, as indicated by positive cytology from lumbar puncture or computed tomography (CT) scan/magnetic resonance imaging. Exceptions include those participants who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids, and do not have neurologic dysfunction that would confound the evaluation of neurologic and other AEs.
- Known human immunodeficiency virus (HIV) infection or HIV-related malignancy, hepatitis B surface antigen positive, or known or suspected active hepatitis C infection.
- History of drug-induced pneumonitis requiring treatment with steroids; history of idiopathic pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Systemic anticancer treatment (including investigational agents) or radiotherapy less than 2 weeks before the first dose of study treatment (\<=4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T-cell engager agents; \<=8 weeks for cell-based therapy or antitumor vaccine).
- Participants in need of immediate cytoreductive therapy.
- Prior autologous stem cell transplant (ASCT) within 6 months or prior ASCT at any time without full hematopoietic recovery, defined by the entry criteria in the study, before Cycle 1 Day 1 or allogeneic stem cell transplant any time.
- Use or consumption of:
- Medications or supplements that are known to be inhibitors of P-glycoprotein (P-gp) and/or strong reversible inhibitors of cytochrome (CYP3A), strong CYP3A mechanism-based inhibitors, strong CYP3A inducers or P-gp inducers within 5 times the inhibitor half-life or within 7 days before the first dose of study drug. In general, the use of these agents is not permitted during the study except in cases in which an AE must be managed.
- Grapefruit-containing food or beverages within 5 days before the first dose of study drug. Note that grapefruit-containing food and beverages are not permitted during the study.
- Active, known, or suspected autoimmune disease. Participants requiring systemic treatment within the past 3 months or with a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include any patient taking 10 mg or less of prednisone or equivalent, participants with vitiligo, hypothyroidism stable on hormone replacement, type 1 diabetes, Graves disease, Hashimoto disease, alopecia areata, eczema, or with medical monitor approval.)
- History of organ or tissue transplant that requires systemic use of immunosuppressive agents.
- Prior treatment with TAK-659 or any spleen tyrosine kinase (SYK) inhibitor or interleukin-2 (IL-2) therapy.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Calithera Biosciences, Inclead
- Nektar Therapeuticscollaborator
Study Sites (6)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Alberta Health Services
Calgary, Alberta, T2N 2T9, Canada
Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de lEstrie - CHUS)
Sherbrooke, Quebec, J1H 5N3, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Millennium Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2018
First Posted
December 11, 2018
Study Start
April 3, 2019
Primary Completion
November 10, 2021
Study Completion
November 17, 2021
Last Updated
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.